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Navigating UAE MOHAP Regulations: A Pure Global Guide to Registering Your Class A Medical Device in Dubai, Abu Dhabi, and Across the Emirates.
In this episode of MENA MedTech Insights, we provide a detailed, step-by-step guide for registering a low-risk, Class A medical device in the United Arab Emirates. We break down the specific requirements set by the UAE's Ministry of Health and Prevention (MOHAP), from the critical first step of appointing a local Authorized Representative to the final submission and review process.
Discover the common pitfalls and nuances that can delay your market entry, even for seemingly simple devices. We explore the importance of proper documentation, including ISO certifications and evidence of approval in reference markets, and explain why every detail matters to UAE regulators. This episode is essential for any MedTech manufacturer looking to tap into the lucrative UAE market efficiently.
Here is a case study. A European startup with an innovative Class A diagnostic tool secured a major distribution deal in Dubai but faced a nine-month delay. Their mistake? They assumed their CE marking was sufficient and their chosen distributor could handle the registration. They discovered their distributor was not a licensed Authorized Representative, and their technical file lacked specific local requirements, forcing a complete restart of the process and jeopardizing their commercial timeline.
This episode's key takeaways:
1. Why is appointing the right Authorized Representative your most critical first step in the UAE?
2. What specific ISO 13485 details will MOHAP scrutinize for your manufacturing site registration?
3. Does a CE mark or FDA approval guarantee a smooth registration for a Class A device?
4. What are the mandatory language requirements for labeling and instructions for use?
5. How can a simple documentation error on a surgical scalpel lead to a complete dossier rejection?
6. What is the real timeline you should expect, from submission to approval?
7. Why must your company be registered before you can even start the device application?
Navigating the complexities of global markets is our specialty. Pure Global offers end-to-end regulatory consulting, combining deep local expertise in over 30 markets with advanced AI tools to accelerate your market access. Whether you're a startup or a multinational, we streamline your path to compliance and commercial success. Do not let regulatory hurdles slow your growth. Contact us for a consultation at [email protected] or learn more by visiting https://pureglobal.com/.
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By Ran ChenIn this episode of MENA MedTech Insights, we provide a detailed, step-by-step guide for registering a low-risk, Class A medical device in the United Arab Emirates. We break down the specific requirements set by the UAE's Ministry of Health and Prevention (MOHAP), from the critical first step of appointing a local Authorized Representative to the final submission and review process.
Discover the common pitfalls and nuances that can delay your market entry, even for seemingly simple devices. We explore the importance of proper documentation, including ISO certifications and evidence of approval in reference markets, and explain why every detail matters to UAE regulators. This episode is essential for any MedTech manufacturer looking to tap into the lucrative UAE market efficiently.
Here is a case study. A European startup with an innovative Class A diagnostic tool secured a major distribution deal in Dubai but faced a nine-month delay. Their mistake? They assumed their CE marking was sufficient and their chosen distributor could handle the registration. They discovered their distributor was not a licensed Authorized Representative, and their technical file lacked specific local requirements, forcing a complete restart of the process and jeopardizing their commercial timeline.
This episode's key takeaways:
1. Why is appointing the right Authorized Representative your most critical first step in the UAE?
2. What specific ISO 13485 details will MOHAP scrutinize for your manufacturing site registration?
3. Does a CE mark or FDA approval guarantee a smooth registration for a Class A device?
4. What are the mandatory language requirements for labeling and instructions for use?
5. How can a simple documentation error on a surgical scalpel lead to a complete dossier rejection?
6. What is the real timeline you should expect, from submission to approval?
7. Why must your company be registered before you can even start the device application?
Navigating the complexities of global markets is our specialty. Pure Global offers end-to-end regulatory consulting, combining deep local expertise in over 30 markets with advanced AI tools to accelerate your market access. Whether you're a startup or a multinational, we streamline your path to compliance and commercial success. Do not let regulatory hurdles slow your growth. Contact us for a consultation at [email protected] or learn more by visiting https://pureglobal.com/.